Shimadzu Medical Systems recalls

Shimadzu Medical Systems has 25 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 13 Apr 2022. 9 are still ongoing.

Total recalls25since 2012

Last 12 months0reported

Class I00% of total

Ongoing9latest 13 Apr 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 25 100%Class III 0 0%

Why shimadzu medical systems is recalled

Product types

By year

2022520%
2020520%
201814%
201728%
201614%
201528%
201428%
201314%
2012624%

Ongoing shimadzu medical systems recalls

9 active

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Device	CLASS II	Model: X-ray R/F System FLUOROspeed X1 recalled	Shimadzu Medical Systems	Other	37 states
13 Apr 2022Device	CLASS II	Model: X-ray TV System Sonialvision G4 recalled	Shimadzu Medical Systems	Other	37 states
13 Apr 2022Device	CLASS II	Model: X-ray TV Sysstem Sonialvision safire17 recalled	Shimadzu Medical Systems	Other	37 states
9 Mar 2022Device	CLASS II	Digital Angiography System Shimadzu Trinias Generator recalled	Shimadzu Medical Systems	Other	15 states
9 Mar 2022Device	CLASS II	Digital Angiography System Bransist safire Generator recalled	Shimadzu Medical Systems	Other	15 states
16 Dec 2020Device	CLASS II	Trinias, Digital Angiography System containing a MH recalled	Shimadzu Medical Systems	Device Malfunction	Nationwide

All shimadzu medical systems recalls, newest first

25 total

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Device	CLASS II	Model: X-ray R/F System FLUOROspeed X1 recalled	Shimadzu Medical Systems	Other	37 states
13 Apr 2022Device	CLASS II	Model: X-ray TV System Sonialvision G4 recalled	Shimadzu Medical Systems	Other	37 states
13 Apr 2022Device	CLASS II	Model: X-ray TV Sysstem Sonialvision safire17 recalled	Shimadzu Medical Systems	Other	37 states
9 Mar 2022Device	CLASS II	Digital Angiography System Shimadzu Trinias Generator recalled	Shimadzu Medical Systems	Other	15 states
9 Mar 2022Device	CLASS II	Digital Angiography System Bransist safire Generator recalled	Shimadzu Medical Systems	Other	15 states
16 Dec 2020Device	CLASS II	Trinias, Digital Angiography System containing a MH recalled	Shimadzu Medical Systems	Device Malfunction	Nationwide
16 Dec 2020Device	CLASS II	Bransist Safire, Digital Angiography System recalled	Shimadzu Medical Systems	Device Malfunction	Nationwide
16 Dec 2020Device	CLASS II	Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 recalled	Shimadzu Medical Systems	Lead & Heavy Metals	Nationwide
16 Dec 2020Device	CLASS II	MH-200S, system with Ceiling Suspended C-arm Support recalled	Shimadzu Medical Systems	Device Malfunction	Nationwide
22 Jul 2020Device	CLASS II	Trinias DAP Meter, a component of the Digital Anglo System recalled	Shimadzu Medical Systems	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.